Business Process Consultant

Job Tittle : Business Process Consultant

The Business Process Consultant in R&D Quality & Risk Management (RDQRM) performs various activities in support of process elaboration, design/mapping, preparation of process diagrams, Quality Document (QD) development and review of Healthcare R&D QDs. Support focuses on ensuring that good process design principles and appropriate documentation standards are consistently applied, that activities are consistently and efficiently coordinated and that deliverables are completed in a high quality and timely manner. Support may also be provided to coordinate audits, audit response processes, and inspections, and to ensure compliance with agreed CAPA due dates, as needed. In addition, the BPC is responsible for coordinating RDQRM training assignments, managing Managed Information documents, and coordinating cross-functional QD reviews.

Key Role Responsibilities

Process Management:

• Supports and guides Business Process Owners (BPOs) and QD Authors in the process of developing or updating process design (end-to-end process design, including setting up expectations, performing process elaboration workshops, coordinating cross-functional alignments, and defining document authoring responsibilities)

• Ensures adherence to Healthcare R&D documentation standards, process orientation, simplification, visualization, harmonized core language, regulatory compliance and harmonization of processes and QDs within Healthcare R&D and RDQRM

• Develops and revises process flow diagrams using the designated system and notation standards, and supports the RDQRM as an expert for efficient process design and illustration

Quality Document Management:

• Develops, reviews, maintains and continuously improves QDs for RDQRM and beyond

• Ensures timely review and revision of existing processes & QDs, maintaining compliance with review and renewal timelines

• Owns RDQRM Managed Information Document Cabinet

• Coordinates review and revision of documents with all appropriate stakeholders in cooperation with BPOs and QD Authors

• Ensures compliance with document content and formatting standards

• Ensures timely and adequate communication within the RDQRM and beyond

Training Management and Oversight:

• Maintains training matrix, coordinates training roles and training assignment, and works with Training Representatives to optimize assignments in RDQRM

Requirements

• >5 years of experience in the pharmaceutical industry or CRO or equivalent 

• Mature leadership and influencing skills, ready to challenge the status quo

• Experience in different functions in the clinical development area is a plus

• Knowledge of ICH Good Clinical Practice (GCP), GLP and GVP guidelines

• Knowledge of Good Documentation Practices

• Solid organizational skills incl. time-management

• Good interpersonal skills

• Demonstrated good written and verbal communication skills

• Fluency in English (oral and written)

• Experienced user of MS Office 365 toolset (Word, Excel, SharePoint, PowerPoint, etc.)

• Experience in process diagramming and process design using tools such as iGrafx or Signavio, and applying BPMN notation

Preferred

• Quality document management experience